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临床试验/NCT04968730
NCT04968730Unknown不适用

Establishment and Application of Early Postoperative Activity Plan for Patients After Hemi-laminectomy for Lumbar Spinal Tumor Resection

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年5月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Patient rehabilitation and leave hospital

研究概览

简要总结

Objective to construct the related early activity program for patients with lumbar intraspinal tumor after hemilaminectomy, and evaluate the postoperative limb function exercise according to the content of the program. In order to improve the self-care ability and quality of life of patients, reduce postoperative complications, shorten the average length of stay, reduce hospitalization expenses and improve patient satisfaction.

Objective to evaluate the efficacy and safety of establishing early activity program after hemilaminectomy for patients with lumbar intraspinal tumors

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with primary benign intraspinal tumors at the level of L1-L5 who underwent semi laminectomy;
  • •The age of the patients ranged from 14 to 80 years old;
  • •The GCS score was 15 points, and the lower limb muscle strength was more than or equal to grade 3 before operation; The patients agreed to the operation and were willing to accept and cooperate with the concept of early rehabilitation nursing and related measures;

排除标准

  • •patients with rapid development of disease, difficult to exclude malignant tumors, and non neoplastic lesions in spine or spinal canal;
  • •Have a history of severe hypertension, heart disease or other mental illness;
  • •Patients with major organ damage or coagulation dysfunction;
  • •The patients and their family members had poor communication and compliance;
  • •There are factors that may progress or worsen the patient's condition (such as uncontrolled infection, severe respiratory disease, pulmonary infection, etc.);

研究组 & 干预措施

control group A

Placebo Comparator

routine nursing after operation

干预措施: Postoperative rehabilitation nursing (Other)

intervention group B

Experimental

Nursing care after operation with stage intervention

干预措施: Postoperative rehabilitation nursing (Other)

结局指标

主要结局

Patient rehabilitation and leave hospital

时间窗: up to two years

The whole clinical courses were strictly controlled in quality so as to compare the average length of stay (days) in the two groups.

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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